Approved Gene Testing (M00041, V14)
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After a review of the current available literature, the MolDX Program has determined that testing for the following genes/gene components meets the Medicare criteria for a covered service. This listing has been updated with 2016 CPT codes.
#
|
CPT Code
|
Description
|
|---|---|---|
1.
|
81170
|
ABL1, ga
|
2.
|
81206
|
BCR_ABL1, majbp qual quant (p210)
|
3.
|
81207
|
BCR_ABL1, minbp qual quant (p190)
|
4.
|
81208
|
BCR_ABL1, other bp qual quant
|
5.
|
81210
|
BRAF, V600E
|
6.
|
81211
|
BRCA1, BRCA2, fgs cdup_del
|
7.
|
81217
|
BRCA2, kfv
|
8.
|
81218
|
CEBPA, fgs
|
9.
|
81225
|
CYP2C19, cv
|
10.
|
81226
|
CYP2D6, cv
|
11.
|
81235
|
EGFR, cv
|
12.
|
81245
|
FLT3, ITD
|
13.
|
81246
|
FLT3, TKD
|
14.
|
81256
|
HFE, cv
|
15.
|
81261
|
IGH, amp
|
16.
|
81262
|
IGH, dp
|
17.
|
81263
|
IGH, var reg
|
18.
|
81264
|
IGK, gr
|
19.
|
81265
|
STR
|
20.
|
81266
|
STR add (for transplants)
|
21.
|
81267
|
Chimerism, no cell
|
22.
|
81268
|
Chimerism, with cell
|
23.
|
81270
|
JAK2, V617F
|
24.
|
81272
|
KIT, tsa
|
25.
|
81273
|
KIT, D816
|
26.
|
81275
|
KRAS, codons 12 and 13
|
27.
|
81275
|
KRAS, exon 1
|
28.
|
81276
|
KRAS, addvar
|
29.
|
81287
|
MGMT, ma
|
30.
|
81288
|
MLH1, ma
|
31.
|
81292
|
MLH1, fgs
|
32.
|
81293
|
MLH1, kfv
|
33.
|
81294
|
MLH1, dup_del
|
34.
|
81295
|
MSH2, fgs
|
35.
|
81296
|
MSH2, kfv
|
36.
|
81297
|
MSH2, dup_del
|
37.
|
81298
|
MSH6, fgs
|
38.
|
81299
|
MSH6, kfv
|
39.
|
81300
|
MSH6, dup_del
|
40.
|
81301
|
MSI
|
41.
|
81310
|
NPM1, exon 12
|
42.
|
81311
|
NRAS, ex 2-3
|
43.
|
81313
|
PCA3
|
44.
|
81314
|
PDGFRA, tsa
|
45.
|
81315
|
PML_RAR, cbp
|
46.
|
81316
|
PML_RAR, sbp
|
47.
|
81317
|
PMS2, fgs
|
48.
|
81318
|
PMS2, kfv
|
49.
|
81319
|
PMS2, dup_del
|
50.
|
81321
|
PTEN, fgs
|
51.
|
81322
|
PTEN, kfv
|
52.
|
81323
|
PTEN, dup_del
|
53.
|
81332
|
SERPINA, cv
|
54.
|
81340
|
TRB, beta
|
55.
|
81341
|
TRB, dp
|
56.
|
81342
|
TRG, gamma
|
57.
|
81370
|
HLA I-II, lr ant
|
58.
|
81371
|
HLA I-II, lr verification
|
59.
|
81372
|
HLA I, lr complete
|
60.
|
81373
|
HLA I, lr locus ea
|
61.
|
81374
|
HLA I, lr 1 ant.
|
62.
|
81375
|
HLA II, lr DRB1/3/4/5, DQB1
|
63.
|
81376
|
HLA II, lr locus ea
|
64.
|
81377
|
HLA II, lr antigen ea
|
65.
|
81378
|
HLA I-II, hr A, B, C, DRB1
|
66.
|
81379
|
HLA I, hr complete
|
67.
|
81380
|
HLA I, hr locus ea
|
68.
|
81381
|
HLA I, hr allele ea
|
69.
|
81382
|
HLA II, hr locus ea
|
70.
|
81383
|
HLA II, hr allele ea
|
71.
|
81400
|
ACE, idv
|
72.
|
81400
|
F13B, V34L
|
73.
|
81400
|
F2, 1199G>A
|
74.
|
81400
|
F5, HR2
|
75.
|
81400
|
F7, R353Q
|
76.
|
81400
|
FGB, -455G>A
|
77.
|
81400
|
HPA, panel
|
78.
|
81400
|
HPA-1
|
79.
|
81400
|
HPA-2
|
80.
|
81400
|
HPA-3
|
81.
|
81400
|
HPA-4
|
82.
|
81400
|
HPA-5
|
83.
|
81400
|
HPA-15
|
84.
|
81400
|
IL28B, rs12979860
|
85.
|
81400
|
SERPINE1, 4G
|
86.
|
81401
|
ABL1, T315I
|
87.
|
81401
|
CBFB_MYH11, cv
|
88.
|
81401
|
CCND1_IGH, ta majbp qual qual
|
89.
|
81401
|
E2A_PBX1, ta qual quan,
|
90.
|
81401
|
EML4_ALK, ta
|
91.
|
81401
|
ETV6_RUNX1, ta qual quan
|
92.
|
81401
|
EWSR1_ERG, ta qual quan
|
93.
|
81401
|
EWSR1_FLI1, ta qual quan
|
94.
|
81401
|
EWSR1_WT1, ta qual quan
|
95.
|
81401
|
F11, cv
|
96.
|
81401
|
FIP1L1_PDGFR, qual quan
|
97.
|
81401
|
FOXO1_PAX3, ta, qual quan
|
98.
|
81401
|
FOXO1_PAX7, ta, qual quan
|
99.
|
81401
|
IGH/BCL2, sbp
|
100.
|
81401
|
MUTYH, cv
|
101.
|
81401
|
PAX8_PPARG, ta
|
102.
|
81401
|
RUNX1_RUNX1T1, ta qual quan
|
103.
|
81401
|
TPMT, cv
|
104.
|
81401
|
TYMS
|
105.
|
81401
|
VWF, cv
|
106.
|
81402
|
IGH_BCL2, majbpr_mcrbp qul_qun
|
107.
|
81402
|
KIT, cv
|
108.
|
81403
|
EPCAM, kfv
|
109.
|
81403
|
F8, intron 1 and 22a
|
110.
|
81403
|
HEA, gs
|
111.
|
81403
|
IDH1, exon 4
|
112.
|
81403
|
IDH1_ IDH2, exon 4 panel
|
113.
|
81403
|
IDH2, exon 4
|
114.
|
81403
|
JAK2, exon 12 and 13
|
115.
|
81403
|
MUTYH, kfv
|
116.
|
81403
| |
117.
|
81403
|
RET, kfv
|
118.
|
81403
|
VHL, dup_del
|
119.
|
81403
|
VWF, tsa 2A, 2B, 2M
|
120.
|
81404
|
CDKN2A, fgs
|
121.
|
81404
|
NRAS, exon 1, 2
|
122.
|
81404
|
PRSS1, fgs
|
123.
|
81404
|
RET, cv
|
124.
|
81404
|
VHL, fgs
|
125.
|
81405
|
MEN1, fgs
|
126.
|
81405
|
RET, tsa
|
127.
|
81405
|
VWF, tsa 2N
|
128.
|
81406
|
RET, fgs
|
129.
|
81445
|
Tsa panel, solid organ neoplasm, 5-50 genes
|
130.
|
81450
|
Tsa panel, hematolymphoid neoplasm, 5-50 genes
|
131.
|
81455
|
Tsa panel, solid organ or hematolymphoid neoplasm, 51 or >
|
132.
|
81479
|
ALK
|
133.
|
81479
|
BCR_ABL1, 210 + 190
|
134.
|
81479
|
BCR_ABL1, 210 + 190 +other
|
135.
|
CALR_MPL
| |
136.
|
81479
|
CYP2D6, CYP2C19
|
137.
|
81479
|
ERBB2
|
138.
|
81479
|
ERCC1
|
139.
|
81479
|
FLT3, ITD + TKD
|
140.
|
81479
|
HER2
|
141.
|
81479
|
IGH, IGK
|
142.
|
81479
|
MYD88, L265P
|
143.
|
81479
|
NRAS, 2,3,4
|
144.
|
81479
|
RET/PTC
|
145.
|
81479
|
ROS1
|
146.
|
81479
|
TRB/TRG
|
The following tests have completed the MolDX Technical Assessment Process and limited coverage has been established. Please review the companion policy and/or article for test specific information.
#
|
Proprietary Test Name
|
Manufacturer
|
Effective Date
|
CPT
|
MCD #
|
MolDX Article #
|
|---|---|---|---|---|---|---|
1.
|
Afirma
|
Veracyte
|
1/1/2012
|
81545
|
A523098
|
M00015
|
2.
|
Allomap
|
XDx
|
2/28/2012
|
81595
|
A53099
|
M00016
|
3.
|
Avise PG
|
Exagen Diagnostics
|
5/1/2012
|
84999
|
A53100
|
M00026
|
4.
|
BRACAnalysis® Rearrangement Test (BART)
|
Myriad Genetics
|
12/1/2006
|
81213
|
L36082
| |
5.
|
BRCA1 Analysis
|
Myriad Genetics
|
12/1/2006
|
81214
|
L36082
| |
6.
|
BRCA1/2
|
Ambry
|
3/1/2014
|
81162
|
L36082
| |
7.
|
BRACAnalysis CDx
|
Myriad Genetics
|
12/19/14
|
81162
|
L36082
|
M00120
|
8.
|
BRCAssureSM
|
LabCorp
|
3/1/2014
|
81162
|
L36082
| |
9.
|
BRCAvantage, Comprehensive
|
Quest
|
3/1/2014
|
81162
|
L36082
| |
10.
|
Breast Cancer Index
|
BioTheranostics
|
11/4/2014
|
81479
|
L35631
| |
11.
|
Cancer26
|
MUSC
|
10/3/2013
|
81445
|
NA
| |
12.
|
CellSearch
|
Veridex
|
5/1/2012
|
86152 OR 86153
|
L35071
| |
13.
|
cobas BRAF
|
Roche
|
9/7/2012
|
81210-22
|
A54018
|
M00111
|
14.
|
cobas EGFR
|
Roche
|
9/5/2013
|
81235-22
|
A54021
|
M00110
|
15.
|
cobas KRAS
|
Roche
|
5/7/2015
|
81275-22
|
A54472
|
M00121
|
16.
|
Comprehensive BRACAnalysis®
|
Myriad Genetics
|
12/1/2006
|
81211
|
L36082
| |
17.
|
Confirm MDx
|
MDx Health
|
11/4/2014
|
81479
|
L35632
| |
18.
|
Corus CAD
|
CardioDx
|
7/30/2012
|
81493
|
A53102
|
M00009
|
19.
|
CTID
|
BioTheranostics
|
12/27/2011
|
81540
|
A53101
|
M00027
|
20.
|
Decipher
|
GenomeDX
|
10/01/2015
|
81479
|
L35868
| |
21.
|
FoundationOne®
|
Foundation One
|
10/01/2015
|
81479
|
L36143
| |
22.
|
GeneSight
|
Assurex Health
|
10/27/2014
|
81479
|
L35633
| |
23.
|
HERmark
|
LabCorp
|
12/9/2011
|
81479
|
A53103
|
M00028
|
24.
|
Integrated BRAC Analysis ®
|
Myriad Genetics
|
12/1/2006
|
81479
|
L36082
| |
25.
|
Mammaprint
|
Agendia
|
11/16/2009
|
81479
|
A53104
|
M00029
|
26.
|
OncotoypeDx Colon
|
Genomic Health
|
9/27/2011
|
81525
|
A53106
|
M00002
|
27.
|
OncotypeDX Breast
|
Genomic Health
|
3/26/2012
|
81479
|
A53105
|
M00003
|
28.
|
PreciseType™ HEA Bead
|
Immucor
|
6/22/2015
|
81403
|
L36074
| |
29.
|
Progensa
|
Gen Probe
|
9/6/2012
|
81313
|
A53107
|
M00013
|
30.
|
Prolaris
|
Myriad Genetics
|
3/2/15
|
81479
|
L35869
| |
31.
|
therascreen EGFR
|
Qiagen
|
9/5/2013
|
81235-22
|
A54021
|
M00110
|
32.
|
therascreen-Kras
|
Qiagen
|
4/30/2013
|
81275-22
|
A54472
|
M00121
|
33.
|
ThxID™ BRAF V600E/K Test
|
bioMerieux, Inc.
|
1/9/2014
|
81210-22
|
A54018
|
M00111
|
34.
|
Tissue of Origin
|
ResponseDx
|
12/22/2011
|
81504
|
A53108
|
M00034
|
35.
|
TRofile DNA
|
LabCorp
|
5/5/2012
|
87999
| ||
36.
|
Trofile
|
LabCorp
|
5/15/2012
|
87999
|
A53528
|
M00042
|
37.
|
Ventana ALK Assay
|
Roche
|
6/12/15
|
88342
|
A54656
|
M00122
|
38.
|
Vectra-DA
|
Crescendo
|
6/30/2012
|
81490
|
A53110
|
M00031
|
39.
|
Vysis
|
Abbott
|
10/2/2012
|
88374 OR 88377
|
A54656
|
M00122
|
